FDA 510(k)

Disposable Nitrile Examination Gloves

N.º K: K203805 · 2021-04-20

SolicitanteJiangsu Yanfang Medical Technology Co., Ltd.

Fecha de decisión2021-04-20

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yanfang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-20 under 510(k) number K203805. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Nitrile Examination Gloves?

Disposable Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-04-20. The listed applicant is Jiangsu Yanfang Medical Technology Co., Ltd.. The 510(k) number is K203805.

When did Disposable Nitrile Examination Gloves receive FDA 510(k) clearance?

Disposable Nitrile Examination Gloves received FDA 510(k) clearance on 2021-04-20, under 510(k) number K203805.

Who is the listed applicant for Disposable Nitrile Examination Gloves?

The FDA 510(k) record lists Jiangsu Yanfang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Examination Gloves?

The FDA product code for Disposable Nitrile Examination Gloves is LZA.

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Otros registros que enlistan a Jiangsu Yanfang Medical Technology Co., Ltd. como solicitante

K212036Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs

Dispositivos relacionados (Código: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fuente oficial

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